VIASURE Real Time PCR Detection Kits
SARS-CoV-2, Flu (A+B) & RSV – BD MAXTM System
VIASURE SARS-CoV-2, Flu (A+B) & RSV Real Time PCR Detection Kit for BD MAX™ System is an automated real-time RT-PCR test designed for the qualitative detection and differentiation of RNA from the SARS-CoV-2, Influenza A (Flu A), Influenza B (Flu B) and/or Human Respiratory Syncytial Virus A/B (RSV) in respiratory samples from individuals suspected of COVID-19 or other respiratory infection by their healthcare provider.
This test is intended to be used as an aid in the identification of the presence of the SARS-CoV-2, Flu A, Flu B and/or RSV viral RNA.
The assay uses the BD MAX™ System for automated extraction of RNA and subsequent real-time RT-PCR employing the reagents provided combined with universal reagents and disposables for the BD MAX™ System.
RNA is extracted from respiratory specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for SARS-CoV-2, Flu A, Flu B and/or RSV.
Human-to-human transmission of the SARS-CoV-2 has been confirmed, even in the incubation period without symptoms, and the virus causes severe respiratory illness like those SARS-CoV produced. Although the pneumonia is the principal illness associated, a few patients have developed severe pneumonia, pulmonary edema, acute respiratory distress syndrome, or multiple organ failure and death. Centers of Disease Control and Prevention (CDC) believes that symptoms of SARS-CoV-2 may appear in as few as 2 days or as long as 14 days after exposure, being the most common fever or chills, cough, fatigue, anorexia, myalgia and dyspnea. Less common symptoms are sore throat, nasal congestion, headache, diarrhea, nausea and vomiting. Loss of smell (anosmia) or loss of taste (ageusia) preceding the onset of respiratory symptoms has also been reported. Older adults and people who have severe underlying medical conditions like heart or lung disease or diabetes seem to be at higher risk for developing more serious complications from COVID-19 illness.
Influenza viruses belong to the Orthomyxoviridae family and cause the majority of viral lower respiratory tract infections. Influenza A and B are a significant cause of morbidity and mortality worldwide, considering that elderly and compromised individuals are especially at risk of developing severe illness and complications such as pneumonia. People feel some or all of these symptoms: fever or feeling feverish/chills, cough, sore throat, nasal stuffiness and discharge, myalgia, headaches, and anorexia. The influenza viruses can be spread from person to person in two different ways: through the air (large droplets and aerosols from sneezing and coughing), and by direct or indirect contact.
Human respiratory syncytial viruses A and B (RSV) belong to the Paramyxoviridae family and are the most important viral agents of acute respiratory infections. RSV is an enveloped, nonsegmented, negative, single stranded linear RNA genome virus. Respiratory syncytial virus is a common contributor of respiratory infections causing bronchitis, pneumonia, and chronic obstructive pulmonary infections in people of all ages. People often feel some or all of these symptoms: rhinorrhea, low-grade fever, cough, sore throat, headache, and wheezing. RSV is transmitted via large nasopharyngeal secretion droplets from infected individuals, close contact, or self-inoculation after touching contaminated surfaces.
Diagnosis can be problematic, as a wide range of pathogens can cause acute respiratory infections presenting with similar clinical syndromes. Real-time PCR assays have been shown to be a sensitive and specific diagnostic tool for the detection of SARS-CoV-2, Flu A, Flu B and RSV viruses.
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CERTIFICATE OF ANALYSIS